Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide (AC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00201708

OSU-0450

Details and patient eligibility

About

This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.

Full description

Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.

Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.

Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.

Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.

Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have histologically or cytologically confirmed breast cancer
• No metastatic disease
• Prior lumpectomy or mastectomy
• No prior chemotherapy or hormone treatments for breast cancer
• Must have normal organ and marrow function.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion criteria

• Peripheral neuropathy of grade II or higher.
• History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
• History of unstable angina or myocardial infarction within the last six months.
• Pregnant or nursing women.
• Known allergies to polysorbate 80.
• HIV-positive patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

Arm A (Docetaxel before doxorubicin/cyclophosphamide)

Active Comparator group

Description:

Docetaxel 75 mg/m2 every 2 weeks for 4 cycles followed by "A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles.

Treatment:

Drug: Cyclophosphamide (AC)

Drug: Doxorubicin

Drug: Docetaxel

Arm B (Docetaxel after doxorubicin/cyclophosphamide)

Active Comparator group

Description:

"A" (doxorubicin) 60 mg/m2 \& "C" (cyclophosphamide) 600 mg/m2 every 2 weeks for 4 cycles followed by Docetaxel 75 mg/m2 every 2 weeks for 4 cycles.

Treatment:

Drug: Cyclophosphamide (AC)

Drug: Doxorubicin

Drug: Docetaxel